AMPLATZER PICCOLO OCCLUDER 9-PDAP-04-04-L

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2020-03-03 for AMPLATZER PICCOLO OCCLUDER 9-PDAP-04-04-L manufactured by Aga Medical Corporation.

Event Text Entries

[183946763] As reported in a research article, left pulmonary artery obstruction were noted during follow up after implantation with a 4-4 amplatzer piccolo. The results of the investigation are inconclusive since the device remains implanted was not returned for analysis. A review of the measurements as reported from the field was performed. Per the sizing table in the instructions for use, arten600042307 version a, the correct size piccolo occluder for the measurements provided was 04-02, smaller than the implanted device. The cause of the reported event could not be conclusively determined, however the implantation of a larger than recommended device could have contributed.
Patient Sequence No: 1, Text Type: N, H10


[183946764] Reference manufacturing report number: 2135147-2020-00090, 2135147-2020-00091, 2135147-2020-00093, 2135147-2020-00094. It was reported through a research article identifying amplatzer piccolo that may be related to a severe left pulmonary artery obstruction. Details are listed in the article, titled "device deformation and left pulmonary artery obstruction after transcatheter patent ductus arteriosus closure in preterm infants. " it was reported in the article that in (b)(6) 2016, 14 patients underwent transcatheter patent ductus arteriosus (pda) closure. An (b)(6) days old patient that weight (b)(6) grams with pda diameter of 1. 89mm and pda length of 7. 89mm was implanted with a 4-4 amplatzer piccolo. During follow up, severe left pulmonary artery obstruction was observed. The patient was asymptomatic and no intervention was performed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2135147-2020-00092
MDR Report Key9783115
Report SourceFOREIGN,HEALTH PROFESSIONAL,L
Date Received2020-03-03
Date of Report2020-03-03
Date of Event2016-12-01
Date Mfgr Received2020-03-02
Date Added to Maude2020-03-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactPAMELA YIP
Manufacturer Street5050 NATHAN LANE N
Manufacturer CityPLYMOUTH MN 55442
Manufacturer CountryUS
Manufacturer Postal55442
Manufacturer Phone6517565400
Manufacturer G1AGA MEDICAL CORPORATION
Manufacturer Street5050 NATHAN LANE NORTH
Manufacturer CityPLYMOUTH MN 55442
Manufacturer CountryUS
Manufacturer Postal Code55442
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAMPLATZER PICCOLO OCCLUDER
Generic NameTRANSCATHETER SEPTAL OCCLUDER
Product CodeMLV
Date Received2020-03-03
Model Number9-PDAP-04-04-L
Catalog Number9-PDAP-04-04-L
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAGA MEDICAL CORPORATION
Manufacturer Address5050 NATHAN LANE NORTH PLYMOUTH MN 55442 US 55442


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-03

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